The Philips Thoravision was submitted as a radiographic system dedicated to chest imaging in 1993. It is now recognized that the system can also be used equally well for examinations of other anatomical areas. This extension to other anatomical areas has required only minor adjustments to the system, primarily in providing APRs addressing those new anatomical areas. As such, the screen layout of the user interface display has changed somewhat. No change has been made to the hardware.

AI/ML Overview

This Philips Thoravision 510(k) submission describes an extension to the intended use of an existing device, not a new device requiring detailed performance studies against specific acceptance criteria. Therefore, the provided text does not contain the requested information regarding acceptance criteria, device performance, or detailed study methodology.

The submission focuses on establishing substantial equivalence for the expanded intended use of an existing system (Philips Thoravision, cleared under K931071) to include all general-purpose radiographic examinations, beyond its original limitation to chest examinations.

Here's what can be extracted and why the other details are missing:

1. Acceptance Criteria and Reported Device Performance

The document does not specify new acceptance criteria or report performance metrics for the device for its expanded intended use. This is because the submission is for a modification of an already cleared device, primarily through software adjustments (APRs - Anatomically Programmed Radiography) and user interface changes, with no hardware modifications. The substantial equivalence argument relies on the existing device's safety and effectiveness.

Missing Information: A table with acceptance criteria and reported device performance is not provided as this type of submission typically defers to the original clearance for such details.

2. Sample Size for Test Set and Data Provenance

Missing Information: The document does not describe a test set or any specific performance studies for the extended indications. It relies on the substantial equivalence to a predicate device (the previously cleared Philips Thoravision chest system). Therefore, sample size and data provenance are not applicable to this particular submission as presented.

3. Number of Experts and Qualifications for Ground Truth

Missing Information: No information is provided regarding experts or ground truth establishment for a test set, as no new performance study data is presented for review in this 510(k) summary.

4. Adjudication Method

Missing Information: No adjudication method is mentioned as there is no new test set or study described in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Missing Information: No MRMC study is mentioned. This type of study would typically be performed for new AI-powered diagnostic tools or significant changes in image interpretation, which is not the subject of this 510(k) extension.

6. Standalone Performance (Algorithm Only)

Missing Information: No standalone performance study is mentioned. The device is a radiographic system, not an independent algorithm for diagnostic interpretation.

7. Type of Ground Truth Used

Missing Information: Since no new performance studies are detailed, the type of ground truth used is not specified.

8. Sample Size for Training Set

Missing Information: The document does not describe a training set. The changes primarily involve software adjustments (APRs) for different anatomical areas, not the development of a new image processing algorithm that would require a training set in the AI sense.

9. How Ground Truth for Training Set Was Established

Missing Information: As no training set is mentioned, the method for establishing its ground truth is also not provided.

In summary, this 510(k) submission is for a minor modification (extension of intended use) of an already cleared medical device, the Philips Thoravision. The core argument for clearance is substantial equivalence to the previously cleared version, rather than presenting new performance data against specific acceptance criteria. Therefore, most of the requested detailed information regarding performance studies and data is not present in this document.

Summary

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JUN 18 1998

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Image /page/0/Picture/1 description: The image shows the Philips logo, which is a shield shape with the word "PHILIPS" at the top. Inside the shield, there are two wavy lines, a four-pointed star at the bottom, and a cross at the top. The logo is in black and white.

Philips Medical Systems

510 (k) Summary of Safety and Effectiveness

Company Name:	Philips Medical Systems North America Company
Address:	710 Bridgeport AvenueShelton, CT 06484
Contact Person	Peter Altman
Telephone Number:	203-926-7031
Prepared (date):	May 7, 1998
Device Name:	Philips Thoravision
Classification Name:	Stationary Diagnostic X-ray System(90 KPR)
Common/Usual Name	General Purpose X-ray system
Predicate Device	Philips Thoravision

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System Description:

Intended Use:

The Philips Thoravision intended use is being extended from its original use (limited to chest examinations) to include radiographic examinations for all anatomical areas.

Substantial Equivalence Information:

This submission introduces an extension to the Thoravision submitted and cleared under 510(k) K931071. This extension provides the capability to use the Thoravision for all general purpose radiographic examinations in addition to the previously cleared chest examinations.

The Philips Thoravision for extended applications is only a minor modification of, and therefore substantially equivalent to, the Philips Thoravision Chest system manufactured by Philips Medical Systems. The Thoravision received 510(k) clearance September 15, 1994 ( see 510(k) K931071).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, creating a monochrome design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 1998

Peter Altman Director of Regulatory Affairs Philips Medical Systems North*America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, CT 06484-0917

Re:

K981657 Philips Thoravision May 8, 1998 Dated: Received: May 11, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR

Dear Mr. Altman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (TDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal. Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Unknown

Philips Thoravision Device Name :

Indications For Use :

The Philips Thoravision is intended for use in general radiographic applications wherever conventional screen-film systems may be used.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Torit A. Seymm
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number

Prescription Use
(Per 21 CFR 801.109

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Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.